SchizophreniaPhase 4NCT03652974
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
A Phase 4 study testing sodium valproate with Clozapine, modified electroconvulsive therapy(MECT) with Clozapine and amisulpride with Clozapine in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
In this study, investigators designed a double-blind randomized trial to compare the efficacy and safety between sodium valproate, amisulpride and MECT combination therapy in clozapine-treated refractory schizophrenia (CTRS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- sodium valproate with Clozapine, modified electroconvulsive therapy(MECT) with Clozapine and amisulpride with Clozapine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2018to 30 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- 18～60 years old
- Clozapine resistance was defined as used at least two antipsychotics with different chemical structures with appropriate dosages for a sufficient duration, and recently have received stable dose of clozapine 400 mg or more per day for at least 6 months.
- Signed an informed consent
Who cannot join
- Patients to be diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for substance abused, development delayed
- Suffering from serious physical disease and can not accept the treatment
- Allergic to sodium valproate, amisulpride, propofol, succinylcholine or atropine
- Participated in any clinical subject within 30 days
- Pregnancy or lactation
- Inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
In this study, investigators designed a double-blind randomized trial to compare the efficacy and safety between sodium valproate, amisulpride and MECT combination therapy in clozapine-treated refractory schizophrenia (CTRS).
Read the detailed description
Schizophrenia is one of the most serious mental illnesses worldwide that affects approximately 1% of the worldwide population and result in a heavy economic burden to affected family. Antipsychotics are the main stay of treatment of schizophrenia, however, there are still approximately 1/3 schizophrenia patients who does not responded to the antipsychotic agents, and these patients easily develop into treatment-refractory schizophrenia (TRS).
Clozapine is the only evidence based effective medication for treatment-refractory schizophrenia (TRS). In spite of its prominent efficacy, approximately 1/3-2/1 treatment-refractory schizophrenia (TRS) treated with clozapine still present with significant residual psychotic symptoms and negative symptoms. As such, over time, clinicians struggled to find strategies to improve outcome by augmenting the concomitant psychiatric treatments, including not only combining antipsychotics but also combining a mood stabilizer or electroconvulsive therapy (ECT).
Clozapine is an antipsychotic drug with multi receptor blocking effect and has a low affinity for dopamine D2. Studies of traditional antipsychotics have suggested that maximal efficacy occurs with dopamine D2 occupancy of 70% or more, while clozapine's dopamine D2 occupancy levels less than 60%. Amisulpride has a highly selective blocking effect on dopamine D2 and dopamine D3 receptors and has no affinity for any other known receptors. Its unique dopamine receptor blocking effect may selectively enhances the limited dopamine D2 blocking effect of clozapine, making it possible to be a suitable and effective drug for combination with clozapine. A number of promising studies that have augmented clozapine with amisulpride, have shown psychiatric symptoms improvement in TRS versus those on clozapine alone.
Both electroconvulsive therapy (ECT) and antiepileptic drugs, such as sodium valproate, shares anticonvulsant properties and anticonvulsant effect relate to clinical efficacy. In 1983, Sackeim et al. pointed out that electroconvulsive therapy (ECT)-induced cortical gamma-aminobutyric-acid (GABA) depletion may be the reason for its anticonvulsant action. In addition, the effect of electroconvulsive therapy (ECT) on the gamma-aminobutyric-acid (GABA) system was confirmed by several studies. Interestingly, it has been reported that the therapeutic effect of sodium valproate combined with antipsychotics is closely related to gamma-aminobutyric-acid (GABA) system.
Growing evidence suggests that the immune, endocrine, and nervous systems interact with each other through cytokines, hormones, and neurotransmitters. The activation of the immune system may be involved in the neuropathological changes occurring in the central nervous system. Among several components of immune pathogenesis, aberrant cytokine signaling is considered as one of the key contributors. Many cytokines have been speculated to be involved in the pathological process of schizophrenia. IL-2 acts as a growth factor for T cells, NK cells and B cells, abnormalities of IL-2 serum levels or its production were found in acute schizophrenia cases. IL-6 is an inflammatory cytokine, which plays significant role in neurobiological functions like neuronal differentiation and survival, synaptic transmission and brain morphometry. The abnormal expression of IL-6 can be found in both first-episode and chronic schizophrenia. TNF-α is one of the most important pro-inflammatory cytokines, which expressed mainly by macrophages. Previous studies have found that the expression of TNF-α is abnormal in patients with schizophrenia.
The primary objective of this study was to compare the efficacy and safety between sodium valproate, amisulpride and MECT combination therapy in clozapine-treated refractory schizophrenia during a 12 weeks period. In addition, the effect of combined therapy on plasma cytokines (IL-2, IL-6 and TNF-α) will be evaluated.
- Conditions
- Schizophrenia
- Being tested
- sodium valproate with Clozapine, modified electroconvulsive therapy(MECT) with Clozapine, amisulpride with Clozapine, placebo with Clozapine
- Keywords
- Schizophrenia， clozapine， amisulpride, valproate， ECT, cytokine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium valproate with ClozapineDrug
Also called Valproate
sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
modified electroconvulsive therapy(MECT) with ClozapineDevice
modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
amisulpride with ClozapineDrug
amisulpride may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
placebo with ClozapineDrug
placebo may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| sodium valproate with clozapine | Experimental | sodium valproate, dosage form: 250 mg, dosage and frequency:250 mg/d for 1 week, 500 mg/d for week 2 , 1000 mg/d for weeks 3, 4, 5, 6, 7 , 8, 9, 10, 11and 12; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks.
Intervention: Drug: sodium valproate with Clozapine Receives: Drug: sodium valproate with Clozapine |
| Modified electroconvulsive therapy with clozapine | Experimental | 12 times MECT for 12 weeks，once a week for the 12 weeks; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks.
Intervention: Device: modified electroconvulsive therapy(MECT) with Clozapine Receives: Device: modified electroconvulsive therapy(MECT) with Clozapine |
| amisulpride | Experimental | amisulpride, dosage form: 200 mg, dosage and frequency:200 mg/d for 1 week, 400 mg/d for week 2,800 mg/d for weeks 3, 4, 5, 6, 7 , 8, 9, 10, 11and 12; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks.
Intervention: Drug: amisulpride with Clozapine Receives: Drug: amisulpride with Clozapine |
| placebo | Placebo comparator | The amisulpride and placebo tablets were identical in appearance. One placebo tablet for the first one week, two placebo tablets for the second week, four placebo tablets for weeks 3, 4, 5, 6, 7 , 8, 9, 10, 11and 12; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks.
Intervention: Drug: placebo with Clozapine Receives: Drug: placebo with Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
The battery of Positive and Negative Syndrome Scale (PANSS) test will be administered in a 30-minute sessions to evaluate the psychiatric symptoms.
Measured: the baseline
Positive and Negative Syndrome Scale (PANSS)
The battery of Positive and Negative Syndrome Scale (PANSS) test will be administered in a 30-minute sessions to evaluate the psychiatric symptoms.
Measured: the end of the six week
Positive and Negative Syndrome Scale (PANSS)
The battery of Positive and Negative Syndrome Scale (PANSS) test will be administered in a 30-minute sessions to evaluate the psychiatric symptoms.
Measured: the end of the twelve week
Scale for the Assessment of Negative Symptoms (SANS)
The Scale for the Assessment of Negative Symptoms (SANS) was applied to assess negative symptoms.
Measured: the baseline
Scale for the Assessment of Negative Symptoms (SANS)
The Scale for the Assessment of Negative Symptoms (SANS) was applied to assess negative symptoms.
Measured: the end of the six week
Scale for the Assessment of Negative Symptoms (SANS)
The Scale for the Assessment of Negative Symptoms (SANS) was applied to assess negative symptoms.
Measured: the end of the twelve week
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was used to evaluate the cognitive performance.
Measured: the baseline
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was used to evaluate the cognitive performance.
Measured: the end of the six week
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was used to evaluate the cognitive performance.
Measured: the end of the twelve week
Clinical Global Impression (CGI)
The Clinical Global Impression (CGI) including severity scale (CGI-S), improvement scale (CGI-I), and efficacy index (CGI-E) was used to evaluate the severity of symptoms and treatment response and treatment effect, respectively.
Measured: the baseline
Clinical Global Impression (CGI)
The Clinical Global Impression (CGI) including severity scale (CGI-S), improvement scale (CGI-I), and efficacy index (CGI-E) was used to evaluate the severity of symptoms and treatment response and treatment effect, respectively.
Measured: the end of the six week
Clinical Global Impression (CGI)
The Clinical Global Impression (CGI) including severity scale (CGI-S), improvement scale (CGI-I), and efficacy index (CGI-E) was used to evaluate the severity of symptoms and treatment response and treatment effect, respectively.
Measured: the end of the twelve week
Treatment Emergent Symptom Scale (TESS)
The Treatment Emergent Symptom Scale (TESS) was used to assess the severity of treatment adverse events.
Measured: the baseline
Treatment Emergent Symptom Scale (TESS)
The Treatment Emergent Symptom Scale (TESS) was used to assess the severity of treatment adverse events.
Measured: the end of the six week
Treatment Emergent Symptom Scale (TESS)
The Treatment Emergent Symptom Scale (TESS) was used to assess the severity of treatment adverse events.
Measured: the end of the twelve week
plasma cytokines IL-2, IL-6 and TNF-α
The plasma cytokines IL-2, IL-6 and TNF-α would be measured using ELISA kits (R \& D Systems, Mississauga, Ontario, CANADA).
Measured: the baseline
plasma cytokines IL-2, IL-6 and TNF-α
The plasma cytokines IL-2, IL-6 and TNF-α would be measured using ELISA kits (R \& D Systems, Mississauga, Ontario, CANADA).
Measured: the end of the twelve week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start6 Sep 2018
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: amisulpride, sodium valproate , placebo and Clozapine amisulpride, sodium valproate and placebo may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia Other Name: Valproate Device: modified electroconvulsive therapy(MECT) with Clozapine modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia Device: Modified electroconvulsive therapy(MECT) with Clozapine
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, The Affiliated Brain Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Zezhi Li, M.D., Principal investigator, Department of Psychiatry, The Affiliated Brain Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652974
- Sponsor's protocol ID
- 81171272
- Status last verified
- Jun 2021
- First submitted
- 25 Aug 2018
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu MH, Liu ZJ, Hu QY, Yang JY, Jin Y, Zhu N, Huang Y, Shi DH, Liu MJ, Tan HY, Zhao L, Lv QY, Yi ZH, Wu FC, Li ZZ. Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial. Mil Med Res. 2022 Oct 18;9(1):59. doi: 10.1186/s40779-022-00420-0.
PubMed 36253804
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
- ClinicalTrials.gov ID
- NCT03652974
- Acronym / sponsor ID
- 81171272
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia， clozapine， amisulpride, valproate， ECT, cytokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, The Affiliated Brain Hospital of Guangzhou Medical University
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators designed a double-blind randomized trial to compare the efficacy and safety between sodium valproate, amisulpride and MECT combination therapy in clozapine-treated refractory schizophrenia (CTRS).
Detailed description
Schizophrenia is one of the most serious mental illnesses worldwide that affects approximately 1% of the worldwide population and result in a heavy economic burden to affected family. Antipsychotics are the main stay of treatment of schizophrenia, however, there are still approximately 1/3 schizophrenia patients who does not responded to the antipsychotic agents, and these patients easily develop into treatment-refractory schizophrenia (TRS).
Clozapine is the only evidence based effective medication for treatment-refractory schizophrenia (TRS). In spite of its prominent efficacy, approximately 1/3-2/1 treatment-refractory schizophrenia (TRS) treated with clozapine still present with significant residual psychotic symptoms and negative symptoms. As such, over time, clinicians struggled to find strategies to improve outcome by augmenting the concomitant psychiatric treatments, including not only combining antipsychotics but also combining a mood stabilizer or electroconvulsive therapy (ECT).
Clozapine is an antipsychotic drug with multi receptor blocking effect and has a low affinity for dopamine D2. Studies of traditional antipsychotics have suggested that maximal efficacy occurs with dopamine D2 occupancy of 70% or more, while clozapine's dopamine D2 occupancy levels less than 60%. Amisulpride has a highly selective blocking effect on dopamine D2 and dopamine D3 receptors and has no affinity for any other known receptors. Its unique dopamine receptor blocking effect may selectively enhances the limited dopamine D2 blocking effect of clozapine, making it possible to be a suitable and effective drug for combination with clozapine. A number of promising studies that have augmented clozapine with amisulpride, have shown psychiatric symptoms improvement in TRS versus those on clozapine alone.
Both electroconvulsive therapy (ECT) and antiepileptic drugs, such as sodium valproate, shares anticonvulsant properties and anticonvulsant effect relate to clinical efficacy. In 1983, Sackeim et al. pointed out that electroconvulsive therapy (ECT)-induced cortical gamma-aminobutyric-acid (GABA) depletion may be the reason for its anticonvulsant action. In addition, the effect of electroconvulsive therapy (ECT) on the gamma-aminobutyric-acid (GABA) system was confirmed by several studies. Interestingly, it has been reported that the therapeutic effect of sodium valproate combined with antipsychotics is closely related to gamma-aminobutyric-acid (GABA) system.
Growing evidence suggests that the immune, endocrine, and nervous systems interact with each other through cytokines, hormones, and neurotransmitters. The activation of the immune system may be involved in the neuropathological changes occurring in the central nervous system. Among several components of immune pathogenesis, aberrant cytokine signaling is considered as one of the key contributors. Many cytokines have been speculated to be involved in the pathological process of schizophrenia. IL-2 acts as a growth factor for T cells, NK cells and B cells, abnormalities of IL-2 serum levels or its production were found in acute schizophrenia cases. IL-6 is an inflammatory cytokine, which plays significant role in neurobiological functions like neuronal differentiation and survival, synaptic transmission and brain morphometry. The abnormal expression of IL-6 can be found in both first-episode and chronic schizophrenia. TNF-α is one of the most important pro-inflammatory cytokines, which expressed mainly by macrophages. Previous studies have found that the expression of TNF-α is abnormal in patients with schizophrenia.
The primary objective of this study was to compare the efficacy and safety between sodium valproate, amisulpride and MECT combination therapy in clozapine-treated refractory schizophrenia during a 12 weeks period. In addition, the effect of combined therapy on plasma cytokines (IL-2, IL-6 and TNF-α) will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Drug: amisulpride, sodium valproate , placebo and Clozapine amisulpride, sodium valproate and placebo may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia Other Name: Valproate Device: modified electroconvulsive therapy(MECT) with Clozapine modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia Device: Modified electroconvulsive therapy(MECT) with Clozapine
| Arm | Type | Receives |
|---|---|---|
| sodium valproate with clozapine | Experimental | Drug: sodium valproate with Clozapinesodium valproate, dosage form: 250 mg, dosage and frequency:250 mg/d for 1 week, 500 mg/d for week 2 , 1000 mg/d for weeks 3, 4, 5, 6, 7 , 8, 9, 10, 11and 12; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks. Intervention: Drug: sodium valproate with Clozapine |
| Modified electroconvulsive therapy with clozapine | Experimental | Device: modified electroconvulsive therapy(MECT) with Clozapine12 times MECT for 12 weeks，once a week for the 12 weeks; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks. Intervention: Device: modified electroconvulsive therapy(MECT) with Clozapine |
| amisulpride | Experimental | Drug: amisulpride with Clozapineamisulpride, dosage form: 200 mg, dosage and frequency:200 mg/d for 1 week, 400 mg/d for week 2,800 mg/d for weeks 3, 4, 5, 6, 7 , 8, 9, 10, 11and 12; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks. Intervention: Drug: amisulpride with Clozapine |
| placebo | Placebo comparator | Drug: placebo with ClozapineThe amisulpride and placebo tablets were identical in appearance. One placebo tablet for the first one week, two placebo tablets for the second week, four placebo tablets for weeks 3, 4, 5, 6, 7 , 8, 9, 10, 11and 12; clozapine, dosage and frequency:300~600 mg/d; duration: 12 weeks. Intervention: Drug: placebo with Clozapine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- 18～60 years old
- Clozapine resistance was defined as used at least two antipsychotics with different chemical structures with appropriate dosages for a sufficient duration, and recently have received stable dose of clozapine 400 mg or more per day for at least 6 months.
- Signed an informed consent
Key exclusion criteria (6 listed)
- Patients to be diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for substance abused, development delayed
- Suffering from serious physical disease and can not accept the treatment
- Allergic to sodium valproate, amisulpride, propofol, succinylcholine or atropine
- Participated in any clinical subject within 30 days
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium valproate with ClozapineAlso: Valproatesodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia | Drug | sodium valproate with clozapine |
| modified electroconvulsive therapy(MECT) with Clozapinemodified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia | Device | Modified electroconvulsive therapy with clozapine |
| amisulpride with Clozapineamisulpride may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia | Drug | amisulpride |
| placebo with Clozapineplacebo may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia | Drug | placebo |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: the baseline
The battery of Positive and Negative Syndrome Scale (PANSS) test will be administered in a 30-minute sessions to evaluate the psychiatric symptoms.
Positive and Negative Syndrome Scale (PANSS)
Time frame: the end of the six week
The battery of Positive and Negative Syndrome Scale (PANSS) test will be administered in a 30-minute sessions to evaluate the psychiatric symptoms.
Positive and Negative Syndrome Scale (PANSS)
Time frame: the end of the twelve week
The battery of Positive and Negative Syndrome Scale (PANSS) test will be administered in a 30-minute sessions to evaluate the psychiatric symptoms.
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: the baseline
The Scale for the Assessment of Negative Symptoms (SANS) was applied to assess negative symptoms.
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: the end of the six week
The Scale for the Assessment of Negative Symptoms (SANS) was applied to assess negative symptoms.
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: the end of the twelve week
The Scale for the Assessment of Negative Symptoms (SANS) was applied to assess negative symptoms.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: the baseline
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was used to evaluate the cognitive performance.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: the end of the six week
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was used to evaluate the cognitive performance.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: the end of the twelve week
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was used to evaluate the cognitive performance.
Clinical Global Impression (CGI)
Time frame: the baseline
The Clinical Global Impression (CGI) including severity scale (CGI-S), improvement scale (CGI-I), and efficacy index (CGI-E) was used to evaluate the severity of symptoms and treatment response and treatment effect, respectively.
Clinical Global Impression (CGI)
Time frame: the end of the six week
The Clinical Global Impression (CGI) including severity scale (CGI-S), improvement scale (CGI-I), and efficacy index (CGI-E) was used to evaluate the severity of symptoms and treatment response and treatment effect, respectively.
Clinical Global Impression (CGI)
Time frame: the end of the twelve week
The Clinical Global Impression (CGI) including severity scale (CGI-S), improvement scale (CGI-I), and efficacy index (CGI-E) was used to evaluate the severity of symptoms and treatment response and treatment effect, respectively.
Treatment Emergent Symptom Scale (TESS)
Time frame: the baseline
The Treatment Emergent Symptom Scale (TESS) was used to assess the severity of treatment adverse events.
Treatment Emergent Symptom Scale (TESS)
Time frame: the end of the six week
The Treatment Emergent Symptom Scale (TESS) was used to assess the severity of treatment adverse events.
Treatment Emergent Symptom Scale (TESS)
Time frame: the end of the twelve week
The Treatment Emergent Symptom Scale (TESS) was used to assess the severity of treatment adverse events.
plasma cytokines IL-2, IL-6 and TNF-α
Time frame: the baseline
The plasma cytokines IL-2, IL-6 and TNF-α would be measured using ELISA kits (R \& D Systems, Mississauga, Ontario, CANADA).
plasma cytokines IL-2, IL-6 and TNF-α
Time frame: the end of the twelve week
The plasma cytokines IL-2, IL-6 and TNF-α would be measured using ELISA kits (R \& D Systems, Mississauga, Ontario, CANADA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: PubMed 36253804Zhu MH, Liu ZJ, Hu QY, Yang JY, Jin Y, Zhu N, Huang Y, Shi DH, Liu MJ, Tan HY, Zhao L, Lv QY, Yi ZH, Wu FC, Li ZZ. Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial. Mil Med Res. 2022 Oct 18;9(1):59. doi: 10.1186/s40779-022-00420-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zezhi Li, M.D. principal investigator
Department of Psychiatry, The Affiliated Brain Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium valproate with Clozapine, modified electroconvulsive therapy(MECT) with Clozapine and amisulpride with Clozapine in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: the baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.